Topic:

Regulatory

Latest Headlines

Latest Headlines

UPDATED: Bristol-Myers' pioneering PD-1 drug Opdivo OK'd by FDA for melanoma

Bristol-Myers Squibb has won a pioneering FDA approval for Opdivo (nivolumab), its top therapeutic asset in the pipeline, as a new therapy for melanoma.

FDA clears NxStage device for 'nocturnal hemodialysis' in another victory for home healthcare

Home healthcare is a buzzphrase these days, and with good justification, including the aging population and a growing focus on cost-cutting within the healthcare system. Now NxStage Medical has won an expanded indication from the FDA for overnight home use of its System One hemodialysis system.

Back from the scrap heap, BioCryst wins OK for IV flu drug

BioCryst Pharmaceuticals won its first-ever FDA approval for a new treatment and subsequently saw its shares slide as analysts yawned over its sales potential.

Cubist scores another FDA nod on the eve of its $9.5B Merck merger

Cubist Pharmaceuticals picked up FDA approval for its latest antibiotic contender, a potential blockbuster whose promise helped bring Merck to the table with a $9.5 billion buyout offer.

UPDATED: NIH launches crowdsourcing challenge to commercialize its neurological medical devices

Taking innovations from the clinic to the commercial market is one of medicine's biggest challenges. This is especially true for government scientists, who face rules and regulations that make it difficult for them to spinout their inventions to startups. But the National Institutes of Health is launching The Neuro Startup Challenge, a crowdsourcing competition featuring 72 teams from 80 hospitals and universities, with a goal of commercializing 16 of its neuroscience inventions, including enhancements to MRI machines. 

AstraZeneca eyes $2B in sales with FDA nod for ovarian cancer fighter Lynparza

AstraZeneca won accelerated FDA approval for its ovarian cancer fighter Lynparza (olaparib), opening the door for potential blockbuster sales of the drug and helping the company distinguish itself from rivals in the BRCA playing field.

Arrowhead submits IND for its RNAi-based hep B candidate

Arrowhead Research Corporation is looking to add another entrant into the clinical trial-based race to commercialize the first  RNAi-based  compound, a market category that could become a new class of drugs akin to monoclonal antibodies and produce revenues exceeding $1 billion by 2020 according to one projection.  The company recently announced that it has submitted its Investigational New Drug application for its  RNAi  candidate, ARC-520, for the treatment of the chronic hepatitis B virus.

Fresenius closes out recall started two years ago

German drugmaker Fresenius Kabi's U.S. operation has completed the recall of half a million vials of drugs started more than two years ago because the glass had fractures and might contain particles.

UPDATED: AbbVie wins blockbuster hep C approval, starts wheeling and dealing on price

AbbVie won an expected FDA approval for its next-generation treatment for hepatitis C, kicking off a race with Gilead Sciences for dominance in a blockbuster field.

Myriad scores FDA approval for ovarian cancer companion Dx

Myriad Genetics won FDA approval for its companion diagnostic test for AstraZeneca's ovarian cancer drug Lynparza, giving the company a boost as it recoups from its latest patent battle loss and helping it gain ground in a fast-growing market.